BEUDAMED
    FDA Recall Terminated

    MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs

    Recall: Z-0228-2016 · Initiated August 31, 2015

    Recall

    Recall Number
    Z-0228-2016
    Event Number
    72096
    Firm
    Pyng Medical Corporation 210-13480 Crestwood Pl Richmond Canada
    FEI Number
    3003437923
    Product Code
    GAX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 31, 2015
    Terminated
    July 5, 2016

    Description

    MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs

    Reason

    Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its Ready position prior to packaging.

    Action

    PYNG Medical sent Recall Notification letters dated August 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: Please immediately cease use of the MATResponder and MATCombat tourniquet lots specified above. Inform all of your teams to cease use of or distribution of these lots. Please immediately place all MATResponder Tourniquets and MATCombat Tourniquets that you have in inventory into a quarantined location. For further questions please call (604) 303-7964. .

    Distribution

    Worldwide Distribution - US Distribution and to the countries of : Colombia, France, Canada, Italy, Germany, Finland, United Kingdom, Australia, The Netherlands, Japan, Hungary, Indonesia, Israel, Mexico, Poland and Spain.

    Quantity

    6728